Myelo Therapeutics GmbH develops innovative treatments in areas of high unmet medical needs. Our lead compound prevents Chemotherapy-induced Neutropenia, the most common and most serious side effect of anticancer therapy. Myelo Therapeutics was selected as one of the “Top 40 High Tech Ventures of the East”. The company was founded 2013 and currently has 9 employees, with offices in Berlin and Dresden.

To lead the clinical development department in our Dresden subsidiary, we are looking for a

Intl. Clinical Operations Manager (m/f) – full time.

Myelo Therapeutics offers an attractive position in a challenging work environment and a lean and non-hierarchical organization. We give our employees a large degree of freedom to drive our scientific and commercial progress and to grow professionally.

As a first project, you will independently lead our ongoing Phase IIa, 160 patients clinical trial in Chemotherapy-induced Neutropenia. For this trial you will manage an external Clinical Research Organisation and a small internal team.
In addition, you will drive the development of our further clinical development as well as regulatory strategy for Europe, the US, and Asia.

You are a good team player, experienced in independently managing clinical trials, ideally in the oncology / haematology field. You are well familiar with ICH-GCP guidelines, as well as interaction with regulatory authorities, especially from the EU and US. You are able to think out of the box and across functional boundaries, able to interact with and lead a diverse group of subject matter experts. A good sense of service, focus on high quality results, open and proactive communication, as well as an eagerness to learn new things make you a well suited candidate.

Specifically, your area of responsibility will be:
- Independent overall execution of a clinical trial in Chemotherapy- induced Neutropenia.
- Leading a small team of internal employees, external subject matter experts, investigators, and the CRO.
- Ensuring the cross-functional team’s compliance with SOPs, ICH-GCP and other applicable guidelines.
- Day-to-day management of clinical trial and project team.
- Managing quality of internal and external work deliverables, project timeline, and budget.
- Oversight of Trial Master File.
- Preparation of regulatory meetings especially with EU and US authorities.

Your profile:
- MD or PhD in Biology, Biochemistry, Clinical Science, or equivalent qualifications.
- At least 5 years of clinical research experience including 3 years of project/operation management experience.
- Experience in independently managing clinical trials under ICH-GCP.
- Experience in leading internal and external teams.
- Expertise of core clinical systems, tools, and metrics.
- Background in Oncology and/or Haematology is a plus.
- Good command of written and spoken English and at least good basic command of German.
- Experience in using MS Office applications.
- “But we have always done it like this” is not part of your repertoire.

The position requires 2 days/week presence in our Dresden office, as well as approx. 2-3 days of traveling/month.
Besides those requirements, we have a flexible home office policy.
If necessary, we can support you in obtaining a German work visa.